REF. ST03 – INTRA / INTER
PROCESSES
COURSE DESCRIPTION
International regulations that govern market authorization for Medical Devices require process control, including notably for sterilization processes.
By applying EN ISO 11137, control of the ionizing radiation sterilization process for medical devices is ensured.
DURATION
1 day / 7 hours
IN-PERSON
VIRTUAL CLASSROOM
OBJECTIVES
- Understand the principles for validation and control of the ionizing radiation sterilization process
- Be able to release sterile batches
- Be able to draw up specifications with the providers involved
- Control the impact of changes on the products
TARGET TRAINEES
Medical Device manufacturers/subcontractors, and more particularly:
- R&D
- Methods
- Production
- Quality Control – Release
PREREQUISITES
- Process qualification concepts
- Some familiarity with microbiology may help better understand the principles relative to the control of sterilization processes
TRAINING RESOURCES
- PowerPoint presentation handed out at the end of training
- Case studies
- Normative references
- Quizzes
COURSE CONTENT
Participants welcomed and presented/Course objectives/Presentation of the course content
- Sterilization processes – General aspects, process validation principles
- A few definitions
- Sterilization by ionizing radiation
- Description of the equipment
- Process steps
- Control parameters
- Validation methodologies
- Process maintenance
- Dose audit
- Source recharging
- Change control
- Subcontracting – Specifications
- Summary/Q&A
- Course evaluation and conclusion
EVALUATION METHODS
- Course evaluation quiz
- Satisfaction survey
- Attendance certificate
This training is assessed based on an evaluation of each individual’s acquisition of knowledge via quizzes during and at the end of the program (success criteria >= 75%).
